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Platelet Rich Plasma for Knee Osteoarthritis

Primary Purpose

Osteo Arthritis Knee, Platelet-rich Plasma

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Platelet-rich plasma
Sponsored by
Pei-Yuan Lee, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Platelet-rich plasma, Osteoarthritis Knee

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 30 and 70 years
  • With diagnosis of osteoarthritis, grade II~grade IV, II-III medial compartment

Exclusion Criteria:

  • Lateral compartment and patellofemoral joint osteoarthritis
  • With prior history of knee surgery
  • Severe varus deformity
  • With current or prior history of traum or infection at the knee
  • With current or prior history of cancer
  • With current or prior history of hematological disease
  • Pregnancy
  • Patients who will not cooperate with one-year followup

Sites / Locations

  • Show Chwan Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRP group

Arm Description

Arthroscopic knee surgery plus intraoperative platelet-rich plasma

Outcomes

Primary Outcome Measures

Change in knee function from baseline to postoperative 3 months
Knee function is evaluated using Oswestry Disability Index preoperatively and 3-month postoperatively.

Secondary Outcome Measures

Change in knee function from baseline to postoperative 6 months
Knee function is evaluated using Oswestry Disability Index preoperatively and 6-month postoperatively.
Change in knee function from baseline to postoperative 12 months
Knee function is evaluated using Oswestry Disability Index preoperatively and 12-month postoperatively.
Change in knee pain from baseline to postoperative 3 months
Pain is evaluated using visual analogue scale preoperatively and 3-month postoperatively.
Change in knee pain from baseline to postoperative 6 months
Pain is evaluated using visual analogue scale preoperatively and 6-month postoperatively.
Change in knee pain from baseline to postoperative 12 months
Pain is evaluated using visual analogue scale preoperatively and 12-month postoperatively.
Percentage of patients with regenerated cartilage
Cartilage regeneration is assessed by pathological biopsy during second look surgery at 12-month postoperative.
Change in cartilage thickness from baseline to postoperative 6 months
Cartilage thickness is assessed by MRI preoperatively and 6-month postoperatively.

Full Information

First Posted
April 13, 2017
Last Updated
September 5, 2019
Sponsor
Pei-Yuan Lee, MD
Collaborators
Aeon Biotechnology Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03197441
Brief Title
Platelet Rich Plasma for Knee Osteoarthritis
Official Title
Intraoperative Platelet Rich Plasma Injection in Arthroscopic Surgery for Osteoarthritis of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 29, 2016 (Actual)
Primary Completion Date
June 28, 2018 (Actual)
Study Completion Date
June 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pei-Yuan Lee, MD
Collaborators
Aeon Biotechnology Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aimed to analyze the effect of platelet-rich plasma (PRP) on knee osteoarthritis. Eligible patients will undertake arthroscopic knee surgery plus intraoperative PRP and also receive second look surgery and intraoperative biopsy.
Detailed Description
Osteoarthritis is a chronic disease defined by progressive degradation of the joint as well as loss of cartilage on joint surfaces. The degeneration that occurs in the joint leads to changes in the catabolic and anabolic activity of chondrocytes. Osteoarthritis may induce pain, stiffness and limitation in range of motion of the joint and also may impact the quality of life. Platelet-rich plasma (PRP) is a fraction of plasma that contains platelets and multiple growth factors concentrated at high level. Because activated platelets have the potential to release growth factors, PRP has been clinically used to accelerate wound healing and tissue regeneration in orthopedic and oral surgery. Although several studies have assessed the effects of PRP on knee osteoarthritis, a higher level of evidence has not been provided. This study aimed to analyze the effect of PRP on knee osteoarthritis. After performing arthroscopic knee surgery plus intraoperative PRP in eligible patients, a second look arthroscopic surgery with intraoperative biopsy will be arranged 6 months later. Pre- and post-operative imaging and clinical outcomes will also be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee, Platelet-rich Plasma
Keywords
Platelet-rich plasma, Osteoarthritis Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRP group
Arm Type
Experimental
Arm Description
Arthroscopic knee surgery plus intraoperative platelet-rich plasma
Intervention Type
Other
Intervention Name(s)
Platelet-rich plasma
Intervention Description
Intraoperative platelet-rich plasma injection during arthroscopic knee surgery
Primary Outcome Measure Information:
Title
Change in knee function from baseline to postoperative 3 months
Description
Knee function is evaluated using Oswestry Disability Index preoperatively and 3-month postoperatively.
Time Frame
3-month postoperative
Secondary Outcome Measure Information:
Title
Change in knee function from baseline to postoperative 6 months
Description
Knee function is evaluated using Oswestry Disability Index preoperatively and 6-month postoperatively.
Time Frame
6-month postoperative
Title
Change in knee function from baseline to postoperative 12 months
Description
Knee function is evaluated using Oswestry Disability Index preoperatively and 12-month postoperatively.
Time Frame
12-month postoperative
Title
Change in knee pain from baseline to postoperative 3 months
Description
Pain is evaluated using visual analogue scale preoperatively and 3-month postoperatively.
Time Frame
3-month postoperative
Title
Change in knee pain from baseline to postoperative 6 months
Description
Pain is evaluated using visual analogue scale preoperatively and 6-month postoperatively.
Time Frame
6-month postoperative
Title
Change in knee pain from baseline to postoperative 12 months
Description
Pain is evaluated using visual analogue scale preoperatively and 12-month postoperatively.
Time Frame
12-month postoperative
Title
Percentage of patients with regenerated cartilage
Description
Cartilage regeneration is assessed by pathological biopsy during second look surgery at 12-month postoperative.
Time Frame
12-month postoperative
Title
Change in cartilage thickness from baseline to postoperative 6 months
Description
Cartilage thickness is assessed by MRI preoperatively and 6-month postoperatively.
Time Frame
6-month postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 30 and 70 years With diagnosis of osteoarthritis, grade II~grade IV, II-III medial compartment Exclusion Criteria: Lateral compartment and patellofemoral joint osteoarthritis With prior history of knee surgery Severe varus deformity With current or prior history of traum or infection at the knee With current or prior history of cancer With current or prior history of hematological disease Pregnancy Patients who will not cooperate with one-year followup
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-Yuan Lee, MD
Organizational Affiliation
Show Chwan Memorial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Show Chwan Memorial Hospital
City
Changhua City
State/Province
Changhua
ZIP/Postal Code
500
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Platelet Rich Plasma for Knee Osteoarthritis

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